MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed a false elevated magnesium result generated on architect c4000 analyzer for one sample.Results provided: customer normal range 1.6 ¿ 2.6 mg/dl.(b)(6) 2023, sid (b)(6), initial result 7.8 mg/dl, repeat result on same analyzer 1.8 mg/dl no impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from magnesium reagent kit, list number 03p68-22, abbott gmbh, max-planck-ring 2, wiesbaden, germany, 65205 to architect c4000, list number 02p24-40, abbott laboratories, 1915 hurd drive, irving, tx, 75038.Mdr number 3016438761-2023-00097 has been submitted and all further information will be documented under that mdr number.H3 other text : after further evaluation, the suspect medical device was changed from magnesium reagent kit, list number 03p68-22 to architect c4000, list number 02p24-40.Mdr number 3016438761-2023-00097 has been submitted and all further information will be documented under that mdr number.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16302835
• MDR Text Key: 308863175
• Report Number: 3002809144-2023-00072
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 46893UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C402081; ARC C4000 INTGR, 02P24-40, C402081